Pregnancy Rate IVFNCT06795984
Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?
An observational study of Pregnancy Rate IVF and Blastocyst IVF, run by Calla IVF Center at 1 site in Romania.
Trial summary
This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Pregnancy Rate IVF, Blastocyst IVF
- What is being tested?
- Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes
- How many people
- 80 participants
- Where
- 1 siteRomania
- Study dates
- 12 Aug 2023to 11 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Adult
Study population: A total of 80 patients were included, with 40 in each group (KIR AA and non-KIR AA). All participants provided written informed consent, and the study protocol was approved by the institutional ethics committee.
Who may be able to join
- Female patients aged 20-40 years.
- Normal uterine cavity confirmed by hysteroscopy or sonohysterography.
- At least three previous failed IVF cycles or a history of recurrent pregnancy loss (RPL).
Who cannot join
- uterine abnormalities,
- systemic autoimmune diseases,
- severe male infertility factors.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Statistical analyses, including logistic regression and ROC curve evaluation, assessed the relationship between CD56 levels, KIR genotype, and implantation success.
- Conditions
- Pregnancy Rate IVF, Blastocyst IVF
- Being tested
- Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succesOther
The analysis aimed to compare CD56 levels between patients with the KIR AA genotype and those without. A multiple linear regression model was used to determine the predictive value of CD56+ levels, KIR genotype, and age on the number of blastocysts.
| Study group | Role | What they receive |
|---|---|---|
| KIR AA (Group A) | In any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). A KIR AA haplotype is defined as cen-A and tel-A Receives: Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes | |
| KIR non AA (Group B) | In any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). KIR Bb haplotype is described as cenB/telB, cenA/telB, or cenB/telA Receives: Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succes |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success.
The value of CD56 NK cell and KIR AA in patients undergoing IVF and pregnancy rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start12 Aug 2023
- Primary completion15 Aug 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Rate IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Calla IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795984
- Sponsor's protocol ID
- CALLAIVF KIR HLAC
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?
- ClinicalTrials.gov ID
- NCT06795984
- Acronym / sponsor ID
- CALLAIVF KIR HLAC
- Conditions
- Pregnancy Rate IVF, Blastocyst IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Calla IVF CenterUniversity, hospital or other
- Study start
- 12 Aug 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Statistical analyses, including logistic regression and ROC curve evaluation, assessed the relationship between CD56 levels, KIR genotype, and implantation success.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIR AA (Group A) | – | Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succesIn any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). A KIR AA haplotype is defined as cen-A and tel-A |
| KIR non AA (Group B) | – | Other: Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succesIn any pregnancy, the maternal KIR genotype could be AA (mostly inhibitory KIRs), AB, or BB (mostly activating KIRs). KIR Bb haplotype is described as cenB/telB, cenA/telB, or cenB/telA |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- A total of 80 patients were included, with 40 in each group (KIR AA and non-KIR AA). All participants provided written informed consent, and the study protocol was approved by the institutional ethics committee.
Key inclusion criteria (3 listed)
- Female patients aged 20-40 years.
- Normal uterine cavity confirmed by hysteroscopy or sonohysterography.
- At least three previous failed IVF cycles or a history of recurrent pregnancy loss (RPL).
Key exclusion criteria (3 listed)
- uterine abnormalities,
- systemic autoimmune diseases,
- severe male infertility factors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Establishing the correlation between KIR AA and KIR non-AA and CD56 endometrial cells and IVF succesThe analysis aimed to compare CD56 levels between patients with the KIR AA genotype and those without. A multiple linear regression model was used to determine the predictive value of CD56+ levels, KIR genotype, and age on the number of blastocysts. | Other | KIR AA (Group A), KIR non AA (Group B) |
Primary outcome
the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success.
Time frame: 12 months
The value of CD56 NK cell and KIR AA in patients undergoing IVF and pregnancy rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Rate IVF and Blastocyst IVF, run by Calla IVF Center at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relationship between endometrial CD56+ NK cells, KIR AA genotypes, and IVF success. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.